Cancer Treatment Today

Daratumumab is a recently approved effective agent in multiple myeloma, and there is great interest in combining it with other effective agents. In heavily pretreated patients with relapsed or relapsed and refractory multiple myeloma, single-agent daratumumab was associated with an overall response rate of 31% and a median overall survival of 20.1 months.On the basis of these findings, daratumumab monotherapy at a dose of 16 mg per kilogram of body weight was approved by the Food and Drug Administration for the treatment of multiple myeloma in patients who have previously received at least three therapies, including a proteasome inhibitor and an immunomodulatory agent, or in patients whose disease is refractory to treatment in both these drug classes.One such combination has been recently reported.

Treatment with daratumumab in combination with proteasome inhibitors and immunomodulatory agents has resulted in high response rates and acceptable safety profiles in early-phase clinical trials. Specifically, in a phase 1 trial involving patients with newly diagnosed multiple myeloma, daratumumab in combination with bortezomib-based regimens, including bortezomib plus dexamethasone, induced responses in all patients.Palumbo reported the results of a prespecified interim analysis of a randomized phase 3 trial of daratumumab in combination with bortezomib and dexamethasone as compared with bortezomib and dexamethasone alone in patients with relapsed or relapsed and refractory multiple myeloma.

Daratumumab with lenalidomide and dexamethasone was associated with a significant progression-free survival benefit and higher rates of overall response and results below the threshold for minimal residual disease than lenalidomide and dexamethasone alone among patients with relapsed or refractory …

Daratumumab with lenalidomide and dexamethasone was associated with a significant progression-free survival benefit and higher rates of overall response and results below the threshold for minimal residual disease than lenalidomide and dexamethasone alone among patients with relapsed or refractory.

Meletios A. Dimopoulos, M.D., Albert Oriol, M.D., Hareth Nahi, M.D., Jesus San-Miguel, M.D., Nizar J. Bahlis, M.D., Saad Z. Usmani, M.D., Neil Rabin, M.B., B.S., Ph.D., Robert Z. Orlowski, M.D., Mieczyslaw Komarnicki, M.D., Kenshi Suzuki, M.D., Torben Plesner, M.D., Sung-Soo Yoon, M.D., Dina Ben Yehuda, M.D., Paul G. Richardson, M.D., Hartmut Goldschmidt, M.D., Donna Reece, M.D., Steen Lisby, M.D., Nushmia Z. Khokhar, M.D., Lisa O’Rourke, M.S.N., Christopher Chiu, Ph.D., Xiang Qin, M.S., Mary Guckert, M.S.N., Tahamtan Ahmadi, M.D., and Philippe Moreau, M.D.Daratumumab, Lenalidomide, and Dexamethasone for Multiple Myeloma. N Engl J Med 2016; 375:1319-1331